STOCK TITAN
  1. Home
  2. Sec-filings
  3. PROF
  4. [8-K] Profound Medical Corp. Reports Material Event

Profound Medical (NASDAQ: PROF) targets higher TULSA throughput

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Profound Medical Corp. introduced new real-time interventional MRI Treatment Delivery Consol (TDC) software for its TULSA-PRO® prostate ablation platform. The software is being deployed across the TULSA-PRO installed base and builds on prior TULSA-AI® modules aimed at improving procedural efficiency, physician experience, and reducing planning complexity.

The upgrade adds real-time iMRI control to put surgeons more directly in control of TULSA-PRO’s supervised robotic autonomy, along with physician-requested user-interface and hardware-control improvements. Profound states that some physicians currently perform up to four TULSA Procedures™ per system per day, and the new software is intended to provide a roadmap for customers to achieve up to six procedures per system per day

Positive

  • None.

Negative

  • None.
Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Potential TULSA procedures per day with roadmap up to 6 TULSA Procedures per system per day Stated objective for throughput using latest TDC software
Current reported TULSA procedures per day up to 4 TULSA Procedures per system per day Reported by a few TULSA physicians today
TULSA-PRO FDA status Cleared by the FDA For transurethral ultrasound ablation (TULSA) of prostate tissue in the United States
Sonalleve FDA status HDE Approved as Humanitarian Device Exemption for osteoid osteomas in the extremities
8-K event date August 17, 2026 Date of press release announcing new TDC software
interventional MRI medical
"an innovator in interventional MRI (iMRI) procedures"
Interventional MRI is the use of magnetic resonance imaging machines during medical procedures to guide needles, catheters or surgical tools in real time, like using a live GPS map inside the body instead of relying on static pictures. For investors, it matters because hospitals and device makers adopting this technology can change procedure costs, reduce complications and open new markets for specialized scanners, instruments and software, affecting revenue, reimbursement and competitive positioning.
TULSA Procedure medical
"Physicians use the TULSA Procedure™ to see, ablate, and confirm therapy"
The Tulsa procedure is a minimally invasive medical treatment for an enlarged prostate that uses targeted pulses of sterile water vapor to destroy excess tissue and relieve urinary blockage. For investors, its clinical adoption, reimbursement status, and ease of use influence demand for the devices, shift patient flow away from long‑term drugs or major surgery, and can materially affect revenue and growth for device manufacturers, hospitals and urology clinics — like a new tool that changes how often and where a condition gets treated.
supervised robotic autonomy technical
"deploys supervised robotic autonomy, meaning it executes predefined and/or AI-driven tasks"
Supervised robotic autonomy is a mode where robots carry out tasks on their own while humans monitor performance, set goals, and intervene for unusual situations or complex decisions. Like a self-driving car with a safety driver, it blends automated execution with human oversight; this affects how quickly systems can be deployed, their operational costs, safety record, and regulatory risk—key concerns for investors assessing growth and stability potential.
incisionless telesurgery medical
"its next potential frontier, including incisionless telesurgery"
Humanitarian Device Exemption regulatory
"Sonalleve is approved by the FDA as HDE in the United States"
A humanitarian device exemption is a regulatory pathway that lets a medical device be approved for use in treating or diagnosing very small patient groups without the usual proof that it works as well as larger treatments; think of it as a special permit for products that serve rare conditions. It matters to investors because it can speed market access and reduce development cost, but the patient pool and sales potential are small and reimbursement or wider adoption may be uncertain.

FAQ

What did Profound Medical (PROF) announce in its August 17, 2026 8-K?
Profound Medical announced new real-time interventional MRI TDC software for its TULSA-PRO® system. The upgrade targets higher procedural efficiency, better physician experience, and reduced planning complexity across the company’s installed base of TULSA-PRO prostate ablation systems.

How could the new TDC software impact TULSA Procedure throughput for PROF?
Profound reports some physicians already perform up to four TULSA Procedures™ per system per day. The company describes the new TDC software as a roadmap that could enable surgeons to perform up to six procedures per system per day, potentially improving system utilization.

What are the key features of Profound Medical’s new real-time iMRI software?
The software adds real-time iMRI control, giving surgeons more direct control of TULSA-PRO’s supervised robotic autonomy. It also incorporates physician-requested interface and hardware-control improvements to support more efficient, personalized prostate tissue ablation workflows.

Which products and indications does Profound Medical (PROF) highlight in this disclosure?
Profound highlights its TULSA-PRO® platform for incision-free prostate ablation and Sonalleve® for non-surgical MRI-guided therapy. Indications mentioned include prostate tissue ablation, uterine fibroids, adenomyosis, osteoid osteoma, desmoid tumors, and pain palliation of bone metastases.

In which markets are Profound Medical’s TULSA-PRO and Sonalleve technologies cleared or approved?
TULSA-PRO is FDA-cleared in the United States and also cleared in Europe, Canada, Saudi Arabia, India, Australia/New Zealand, and the UAE. Sonalleve® holds FDA HDE status for certain osteoid osteomas and is cleared or approved in Europe, Canada, China, and Saudi Arabia.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
Understanding 8-K Material Events →
False000162880800016288082026-08-172026-08-17iso4217:USDxbrli:sharesiso4217:USDxbrli:shares
 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_________________

FORM 8-K

_________________

CURRENT REPORT

Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  August 17, 2026

_______________________________

PROFOUND MEDICAL CORP.

(Exact name of registrant as specified in its charter)

_______________________________

Ontario, Canada001-39032Not Applicable
(State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification No.)

2400 Skymark Avenue, Unit 6

Mississauga, Ontario, Canada L4W 5K5

(Address of Principal Executive Offices) (Zip Code)

Registrant's Telephone Number, Including Area Code: 647-476-1350

 

 

(Former name or former address, if changed since last report)

_______________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Shares, No Par Value Per SharePROFThe Nasdaq Stock Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 
 
Item 7.01. Regulation FD Disclosure.

 

On August 17, 2026, Profound Medical Corp. (the “Company” or “Profound”) issued a press release announcing the introduction of the Company’s new real-time interventional MRI Software. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.          

 

The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or the Exchange Act, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, or the Securities Act. The information in this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into any other filing with the U.S. Securities Exchange Commission, or the SEC, made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No. Description
99.1 Press Release, dated August 17, 2026
104 Cover Page Interactive Data File (embedded within Inline XBRL document)
 
 

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 PROFOUND MEDICAL CORP.
   
  
Date: August 17, 2026By: /s/ Arun Menawat        
  Arun Menawat
  Chief Executive Officer and Chairman
  

 

EXHIBIT 99.1

Profound’s Introduction of New Real-time Interventional MRI Software Paving the Way for Full ‘TULSA Days’

Most recent TDC software provides a potential roadmap for customers to easily achieve up to 6 TULSA Procedures™ per system per day 

TORONTO, Aug. 17, 2026 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets innovative interventional MRI (“iMRI”) procedures, today announced the introduction of its latest Treatment Delivery Consol (“TDC”) software.

The new TDC software, which is being deployed across Profound’s TULSA-PRO® installed base, further builds upon previously implemented TULSA-AI® modules focused on increasing procedural efficiency and physician experience, while reducing planning complexity. It brings two new focuses of features that are designed to even further increase TULSA Procedure™ efficiency and support the ability to regionally ablate tissue for a variety of prostate indications:

  • Real-time iMRI control, putting the surgeon more squarely in the driver’s seat of TULSA-PRO’s supervised robotic autonomy.
  • Physician-requested improvements to the user interface and hardware control.

“Today, a few TULSA physicians already report being able to perform up to four TULSA Procedures per day,” said Arun Menawat, Profound’s CEO and Chairman. “Many TULSA physicians also report that TULSA-PRO is already one of the least stressful devices they use. The objective of introducing the latest TDC software is to further increase ease of use and reduce overall procedure times, and provide what we believe is a roadmap that would allow surgeons to achieve up to six procedures per day.”

Dr. Menawat continued, “TULSA is the only prostate treatment modality that deploys supervised robotic autonomy, meaning it executes predefined and/or AI-driven tasks independently. This compares to competitive ‘master-slave’ robotic systems that instead rely on direct, real-time human hand movement and control. Putting physicians more squarely in the driver’s seat of TULSA-PRO’s autonomous robotics via this software upgrade will further enhance their ability to deliver consistent, highly personalized prostate ablation based on each patient's unique anatomy and disease. In the future, it may also give us an even stronger competitive advantage as prostate surgery advances to its next potential frontier, including incisionless telesurgery.”

About Profound Medical Corp.

Profound is a commercial-stage medical device company and an innovator in interventional MRI (iMRI) procedures. The company’s flagship platform, TULSA-PRO®, enables MRI-guided, incision-free prostate ablation. Physicians use the TULSA Procedure™ to see, ablate, and confirm therapy in real time, supporting personalized treatment strategies across the continuum of prostate care—from whole-gland to subtotal, hemi, multifocal, and focal treatment. This approach enables individualized care using prostate tissue ablation, while minimizing the potential of the side effects that are typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction.

Profound also commercializes Sonalleve®, an MRI-guided therapy that provides a non-surgical treatment option for pain palliation of bone metastases, desmoid tumors, and osteoid osteoma, as well as for common gynecologic conditions including uterine fibroids and adenomyosis. Sonalleve delivers targeted therapy with no incisions, no blood loss during the procedure, no overnight hospital stay, and faster recovery — and, in gynecologic applications, enables uterine-sparing treatment that may help preserve fertility. Profound is also exploring additional clinical applications for Sonalleve, including non-invasive ablation of abdominal cancers and hyperthermia-based cancer therapies.

Profound Medical’s technologies are approved across major global markets. TULSA-PRO is cleared by the FDA in the United States for transurethral ultrasound ablation (TULSA) of prostate tissue. In addition, TULSA-PRO is cleared for use in various jurisdictions including Europe, Canada, Saudi Arabia, India, Australia/New Zealand, and the UAE. Sonalleve is approved by the FDA as HDE in the United States for the treatment of osteoid osteomas in the extremities. Sonalleve is also cleared or approved in the Europe, Canada, China, and Saudi Arabia.

Through real-time MRI guidance and data-driven innovation, Profound is advancing the future of MRI-guided therapy — expanding access to precise, personalized, and incision-free treatment options worldwide.

Forward-Looking Statements

This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technologies for disease conditions requiring MR-Guided ablation procedures for prostate, uterine fibroids, adenomyosis, palliative pain treatment, desmoid tumors, and osteoid osteoma; Profound’s expectations for future revenues/financial results; and the success of Profound’s commercialization strategy and activities for TULSA-PRO® and Sonalleve®. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Other factors and risks that may cause actual results to differ materially from those set out in the forward-looking statements are described in Profound's Annual Report on Form 10-K and other filings made with U.S. and Canadian securities regulators, available at www.sedarplus.com and www.sec.gov. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.

For further information, please contact:

Stephen Kilmer
Investor Relations
skilmer@profoundmedical.com  
T: 647.872.4849

Susan Thomas
Public Relations
sthomas@profoundmedical.com
T: 619.540.9195

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

5 documents

Press Releases

Other Documents